| CTRI Number |
CTRI/2015/11/006356 [Registered on: 13/11/2015] Trial Registered Retrospectively |
| Last Modified On: |
12/11/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of sucrose solution to decrease pain in newborn babies |
|
Scientific Title of Study
|
Effectiveness of sucrose analgesia for procedural pain in term neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VEERA LOKANADHA REDDY M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPT OF PAEDIATRICS,
KMC, MANIPAL
MADHAVA NAGAR,
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7795164537 |
| Fax |
|
| Email |
lokanath007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leslie E Lewis |
| Designation |
Professor and Head |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
NICU division,
Dept of Paediatrics,
Kasturba Medical College
Madhava nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslielewis1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VEERA LOKANADHA REDDY M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPT OF PAEDIATRICS,
KMC, MANIPAL
MADHAVA NAGAR,
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7795164537 |
| Fax |
|
| Email |
lokanath007@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANIPAL |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VEERA LOKANADHA REDDY M |
kasturba Hospital, Manipal |
Neonatal Intensive Care Unit,
Division of Neonatalogy,
1st Floor, Dept. of Paediatrics,
Women and Child Block
Kasturba Hospital,Manipal
Udupi
KARNATAKA |
7795164537
lokanath007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA HOSPITAL, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal new born babies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10% Dextrose |
1ml/dose, 2 minutes prior to the procedure. Only once per child per procedure. |
| Intervention |
24% sucrose |
1ml/dose, 2 minutes prior to the procedure. Only once per child per procedure. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Healthy term neonates |
|
| ExclusionCriteria |
| Details |
Neonates with severe medical illnesses |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NIPS score
0-2:mild to no pain
3-4:moderate pain
more than 4:severe pain
SPO2
Heart rate
Mean Cry time |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary cortisol |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/08/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Neonates feel more pain than adults for the same intensity of pain stimulus.But neonatal pain is poorly understood and mostly ignored.Long term outcomes of severe neonatal pain during procedures will cause behavioural changes. Hence there is necessity to reduce pain in neonates during procedures.Sucrose is being tried as an analgesic agent for neonatal pain but in India no studies have been reported.Our hypothesis is 24% sucrose is an effective analgesic for neonatal procedural pain. |